FDA label 794fda80-31e5-4728-ba23-30de6e70cf7f

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
6f087a47-36f7-4a9c-aa45-8d174bc3212f
SPL ID
794fda80-31e5-4728-ba23-30de6e70cf7f
Version
19
Effective date
2023-10-09
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:44:16

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only Do not use for external feminine itching if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with the eyes • do not begin the use of any other hydrocortisone product unless directed by a doctor for external anal itching: • do not use more than directed unless directed by a doctor • do not put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if • symptoms last for more than 7 days • the condition gets worse • symptoms clear up and occur again in a few days • rectal bleeding occurs, consult doctor promptly Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.